REFORM PEDICLE SCREW SYSTEM— 510(k) K130279

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K130279 for REFORM PEDICLE SCREW SYSTEM, Substantially Equivalent on 2013-06-20. Applicant: Spinal USA.

Clearance details

Applicant: Spinal USA
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2013-02-05
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.